Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study
The goal of this observational study is to learn whether a participant's understanding of the informed consent information is related to the amount of propofol needed during endobronchial ultrasound (EBUS). EBUS is a procedure that uses a thin camera and ultrasound to look at lymph nodes and other areas inside the chest. Propofol is a sedative medicine used to help participants stay comfortable during the procedure.
Before EBUS, all participants will receive the usual information about the procedure as part of routine care. After this routine consent process, participants will answer short questions about what they understood. They will also answer questions about their anxiety before the procedure. The study will not change the usual consent process, sedation plan, or medical care.
During EBUS, participants will receive usual sedation and monitoring according to routine clinical practice. The research team will record how much sedative medicine is used, whether extra sedation is needed, whether any important clinical events occur, and how participants recover after sedation. The main question is whether participants who understand the consent information better need less propofol during EBUS.
Descripción general del estudio
Estado
Descripción detallada
Endobronchial ultrasound (EBUS) is a minimally invasive bronchoscopic procedure commonly used to evaluate mediastinal and hilar lymph nodes and other intrathoracic lesions. Because airway stimulation, coughing, and patient movement may occur during the procedure, sedation is commonly used to improve patient comfort and procedural tolerance.
This prospective observational study will evaluate the relationship between participants' understanding of the informed consent information and their sedative requirement during EBUS. All participants will undergo the routine clinical informed consent process before the procedure. After this process, their understanding of the procedure will be assessed using a structured consent understanding assessment form developed by the investigators. Preprocedural anxiety will also be evaluated using a validated anxiety scale.
The study will not assign participants to any intervention and will not modify routine clinical care. Sedation, monitoring, and procedural management will be performed according to usual clinical practice. The research team will record perioperative data related to sedative medication use, need for additional sedation, sedation-related clinical events, and early recovery after the procedure. The planned analysis will assess whether a higher level of consent understanding is associated with lower propofol requirement during EBUS, while considering relevant clinical factors.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gokce Kizilkale Kayikci, MD
- Número de teléfono: +90 533 735 63 97
- Correo electrónico: gkizilkale@uludag.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Leman Gokcenur Aydin, MD
- Número de teléfono: +90 224 295 32 76
- Correo electrónico: lgaydin@uludag.edu.tr
Ubicaciones de estudio
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Bursa
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Bursa, Bursa, Turquía (Türkiye), 16059
- Reclutamiento
- Bursa Uludag University Faculty of Medicine Hospital
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Contacto:
- Gökçe Kızılkale Kayıkcı, MD
- Número de teléfono: +90 533 735 6397
- Correo electrónico: gkizilkale@uludag.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective endobronchial ultrasound
- ASA physical status I to III
- Ability to read and understand Turkish
- Provision of written informed consent for study participation
Exclusion Criteria:
- Active psychiatric disease that may affect the informed consent process, anxiety assessment, or communication
- Cognitive impairment, including dementia or delirium
- Contraindication or known allergy to propofol, midazolam, or remifentanil
- Emergency EBUS procedure
- Regular anxiolytic or sedative drug use within the last month
- Illiteracy
- Turkish language barrier
- Advanced organ failure or decompensated systemic disease that may significantly affect sedative drug response, hemodynamic stability, communication, or consent assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Adults Undergoing Elective Endobronchial Ultrasound
Adult participants scheduled for elective endobronchial ultrasound under routine clinical sedation.
Participants will complete a structured assessment of consent understanding and a preprocedural anxiety assessment before the procedure.
Sedative medication use, need for additional sedation, relevant clinical events, and early recovery after sedation will be recorded according to the study protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption
Periodo de tiempo: From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure
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The association between the Pre-EBUS Consent Understanding Teach-Back Scale score and intraoperative propofol consumption will be evaluated.
The Pre-EBUS Consent Understanding Teach-Back Scale is an investigator-developed scale administered after signing the informed consent form and before the EBUS procedure.
It consists of 10 items, each scored from 0 to 2, yielding a total score ranging from 0 to 20.
Higher scores indicate better understanding of the procedure, sedation, potential risks, and post-procedural precautions.
Propofol consumption will be calculated as the total propofol dose adjusted for body weight and procedure duration and expressed as mg/kg/hour.
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From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association Between Consent Understanding Score and Preoperative Anxiety Score
Periodo de tiempo: On the day of the procedure, before initiation of EBUS sedation
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Preoperative anxiety will be assessed using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale.
The anxiety subscale consists of four items scored from 1 to 5, yielding a total score ranging from 4 to 20.
Higher scores indicate higher preoperative anxiety.
The Pre-EBUS Consent Understanding Teach-Back Scale consists of 10 items, each scored from 0 to 2, yielding a total score ranging from 0 to 20, with higher scores indicating better understanding.
The association between the Pre-EBUS Consent Understanding Teach-Back Scale score and the Amsterdam Preoperative Anxiety and Information Scale anxiety subscale score will be evaluated.
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On the day of the procedure, before initiation of EBUS sedation
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Additional Propofol Requirement During EBUS
Periodo de tiempo: During the EBUS procedure
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The need for additional propofol administration or an increase in propofol infusion during EBUS will be recorded according to clinical requirements.
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During the EBUS procedure
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Intraoperative Remifentanil Consumption
Periodo de tiempo: During the EBUS procedure
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Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.
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During the EBUS procedure
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Bispectral Index Course During Sedation
Periodo de tiempo: During the EBUS procedure
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Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.
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During the EBUS procedure
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Early Recovery Characteristics After Sedation
Periodo de tiempo: At 15 minutes after completion of the EBUS procedure
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Early recovery after EBUS sedation will be assessed using the Modified Aldrete Score.
The Modified Aldrete Score evaluates activity, respiration, circulation, consciousness, and oxygen saturation.
Each component is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate better post-sedation recovery.
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At 15 minutes after completion of the EBUS procedure
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Patient Satisfaction After Sedation
Periodo de tiempo: At 30 minutes after completion of the EBUS procedure
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Patient satisfaction after EBUS sedation will be assessed using a 5-point Likert-type satisfaction scale.
The score ranges from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater patient satisfaction.
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At 30 minutes after completion of the EBUS procedure
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
- Wahidi MM, Herth F, Yasufuku K, Shepherd RW, Yarmus L, Chawla M, Lamb C, Casey KR, Patel S, Silvestri GA, Feller-Kopman DJ. Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report. Chest. 2016 Mar;149(3):816-35. doi: 10.1378/chest.15-1216. Epub 2016 Jan 12.
- Cetinkaya F, Kavuran E, Unal Aslan KS. Validity and reliability of the Amsterdam Preoperative Anxiety and Information Scale in the Turkish population. Turk J Med Sci. 2019 Feb 11;49(1):178-183. doi: 10.3906/sag-1806-84.
- Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009 Sep;198(3):420-35. doi: 10.1016/j.amjsurg.2009.02.010.
- Casal RF, Lazarus DR, Kuhl K, Nogueras-Gonzalez G, Perusich S, Green LK, Ost DE, Sarkiss M, Jimenez CA, Eapen GA, Morice RC, Cornwell L, Austria S, Sharafkanneh A, Rumbaut RE, Grosu H, Kheradmand F. Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation. Am J Respir Crit Care Med. 2015 Apr 1;191(7):796-803. doi: 10.1164/rccm.201409-1615OC.
- Grendelmeier P, Kurer G, Pflimlin E, Tamm M, Stolz D. Feasibility and safety of propofol sedation in flexible bronchoscopy. Swiss Med Wkly. 2011 Aug 26;141:w13248. doi: 10.4414/smw.2011.13248. eCollection 2011.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BUU-EBUS-CUP-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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